NCT04447573Unknown不适用
Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma
Hebei Senlang Biotechnology Inc., Ltd.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy: Overall Remission Rate (ORR)
研究概览
简要总结
This study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma
详细描述
This is a study to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma.
The Main research objectives:
To evaluate the safety and efficacy of BCMA CAR-T in patients with relapsed or refractory multiple myeloma
The Secondary research objectives:
To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or refractory multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
- •According to the international standard for multiple myeloma (IMWG 2014);
- •Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were defined as follow. Relapsed: patients had received for at least 3 drugs with different mechanisms of action (including protease inhibitors and immunomodulators) and disease progression within 60 days of the most recent treatment. Refractory was defined as: disease progression occurred during the recent treatment, or disease progression occurred within 60 days after treatment;
- •The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
- •No antibody drug was administered within last 2 weeks before cell therapy;
- •ECOG Scores: 0~1
- •Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥ 50%, no serious arrhythmia;
- •The subjects had no pulmonary infection, normal pulmonary function, and indoor air oxygen saturation ≥ 92%;
- •There was no contraindication for peripheral blood sampling;
- •The estimated survival time was more than 12 weeks;
- •The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation; the female or male subjects of childbearing age should take effective contraceptive measures during the whole research process.
排除标准
- •Have a history of allergy to any component of cell products;
- •There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to the functional classification method of the New York Heart AssociationNYHA) with a history of myocardial infarction, angioplasty or stent implantation, unstable angina or other clinically significant heart disease within 12 months before admission;
- •who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- •Patients who need urgent treatment due to tumor progression or spinal cord compression;
- •The investigator determines that there are serious complications or diseases that will increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis, recent major trauma, etc;
- •After allogeneic hematopoietic stem cell transplantation;
- •Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive （excluding glucocorticoid）therapy;
- •There was uncontrolled active infection;
- •There were live vaccinations within 4 weeks before admission;
- •Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
- •Subjects had a history of alcohol, drug or mental illness;
- •The researchers believe that there are other conditions that subjects are not suitable to participate in this study.
结局指标
主要结局
Efficacy: Overall Remission Rate (ORR)
时间窗: 3 months post CAR-T cells infusion
Overall Remission Rate (ORR) including partial remission and complete
Safety: Incidence and severity of adverse events
时间窗: First month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
次要结局
- CAR-T proliferation(3 months post CAR-T cells infusion)
- Efficacy: progression-free survival (PFS)(24 months post CAR-T cells infusion)
- Cytokine release(First month post CAR-T cells infusion)
- Efficacy:duration of response (DOR)(24 months post CAR-T cells infusion)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
早期 1 期
BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple MyelomaRelapsed and Refractory Multiple MyelomaNCT03661554The Pregene (ShenZhen) Biotechnology Company, Ltd.15
招募中
早期 1 期
A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple MyelomaRelapse Multiple MyelomaRefractory Multiple MyelomaNCT05430945Zhejiang University100
招募中
2 期
BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCTMultiple MyelomaNCT05846737Institute of Hematology & Blood Diseases Hospital, China20
Unknown
1 期
Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple MyelomaMultiple Myeloma in RelapseNeoplasm, Plasma CellMultiple MyelomaNCT04272151Chongqing Precision Biotech Co., Ltd40
招募中
1 期
Novel BCMA-targeted CAR-T Cell Therapy for Multiple MyelomaRelapsed or Refractory Multiple MyelomaNCT04706936Second Affiliated Hospital, School of Medicine, Zhejiang University25